1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-10-24 to 1990-01-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted Feb 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

adopted Mar 1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

EC Number:

229-175-3

EC Name:

1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

Cas Number:

6422-83-9

Molecular formula:

C15H10N2O4

IUPAC Name:

1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9 weeks (males), 11 weeks (females)
- Weight at study initiation: 192-209 g (males), 172-183 g (females)
- Fasting period before study: 12-18 h
- Housing: Groups of five animals in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Kliba 343, Batch 55/89 rat maintenance diet ("Kliba", Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum.
- Water: Community tap water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

bi-distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortality/Viability: four times on Day 1 and daily thereafter until Day 15
Body Weights: on Day 1 (pre-administration), 8 and 15
Clinical Signs: four times during Day 1 and daily thereafter until Day 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred up to the end of the 14-day observation period.

Clinical signs:

Hunched posture was observed in one male on Day 1 after treatment. Ruffled fur was observed in 3 males between Day 1 and 6 and in 2 females between Day 1 and 3. No clinical signs were observed in males and females from Day 7 and 4, respectively, until the end of the study.

Body weight:

The body weight gain of the animals was not affected by the test article treatment throughout the entire study period.

Gross pathology:

Macroscopical findings were limited to one male animal showing pale discolouration of the lungs and clay-coloured left lateral lobe of the liver. No abnormalities were observed in the remaining males and in any females.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 in male and female Wistar rats was determined to be greater than 2000 mg/kg bw. There were no treatment-related deaths and no abnormal changes in body weight. Clinical signs (hunched posture and ruffled fur) were observed in a few males and were fully reversible by study Day 7. Macroscopical findings (pale discolouration of the lungs and clay-coloured left lateral lobe of the liver) were limited to one male animal.
Based on the study results, the substance does not fulfil the criteria for classification in accordance with Regulation (EC) 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and is thus considered to be not acutely toxic by the oral route.